MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH COMPACT MALE URINARY INTERMITTENT DRAINAGE CATHETER; SINGLE-ADMINISTRATION URETHRAL DRAINAGE CATHETER

Catalog Number 28692 / 286920

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Hematuria (2558)

Event Date 11/02/2023

Event Type  Injury  

Event Description

According to the available information, a male end-user used the speedicath compact male catheter.The end-user said the catheterisation felt weird, but that the urine drained normally.When the end-user withdrew the catheter there was bleeding afterwards.The bleeding was described to continue for 24 hours, with the exception of the night-time.After the 24 hours the end-user contacted coloplast.The end-user was advised to contact a health care professional (hcp), which he did, and was told to monitor the bleeding for the weekend.After 4 hours, the end-user felt bad, and after an additional hour he developed a fever (38.5°c) and felt sick.He contacted the hcp again and was told to go the emergency room.The end-user went to the emergency room by ambulance and spent the weekend there.Several tests were performed, in which one showed escherichia coli (e.Coli) in the urine, for which the end-user was prescribed treatment with antibiotics for 10 days.No further information is available at this time.

• Brand Name: SPEEDICATH COMPACT MALE URINARY INTERMITTENT DRAINAGE CATHETER
• Type of Device: SINGLE-ADMINISTRATION URETHRAL DRAINAGE CATHETER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usgab giovanna abugre ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18160121
• MDR Text Key: 328405764
• Report Number: 3006606901-2023-00017
• Device Sequence Number: 1
• Product Code: GBM
• UDI-Device Identifier: 05708932579032
• UDI-Public: 05708932579032
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K143182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 28692 / 286920
• Device Lot Number: 9098259_2869201032
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male